Abatacept (Orencia)

How does it work?

Orencia infusion and injection contain the active ingredient abatacept, which is a type of medicine called a selective immunosuppressant. It is used to treat severe forms of rheumatoid arthritis. Rheumatoid arthritis is known as an autoimmune disease, because the inflammation and damage to the joints results from overactivity in the immune system. Abatacept works by suppressing part of the immune system and modifying the process of inflammation.

Abatacept works by binding to cells called antigen presenting cells, which are important cells in the immune system. By binding to the surface of these, abatacept prevents them from binding with other important immune cells called T-lymphocytes. Normally when antigen presenting cells bind with T-lymphocytes, this activates the T-cells, setting off a chain reaction that results in inflammation.

The activated T-lymphocytes multiply in numbers and directly cause inflammation themselves. They also produce substances that cause inflammation, such as interleukins and TNF alfa, as well as activating other inflammatory cells.

By preventing the antigen presenting cells from binding to the T-lymphocytes, abatacept stops them activating the T-lymphocytes. This stops the T-lymphocytes from producing these inflammatory responses.

In arthritic conditions, treatment with abatacept reduces the movement of inflammatory cells into inflamed areas of the joints. This reduces the signs and symptoms of the arthritis, improves physical function of the joints and reduces the rate of joint damage. It also reduces the presence of other inflammatory markers. When treating arthritis, abatacept is referred to as a disease-modifying antirheumatic drug or DMARD.

What is it used for?

Moderate to severe rheumatoid arthritis.

Arthritis with no known cause affecting several joints, in children aged six years and over (polyarticular juvenile idiopathic arthritis).

Abatacept is used in combination with methotrexate, when other disease modifiying antirheumatic drugs (DMARDs, including a TNF-alpha inhibitors such as infliximab, etanercept or adalimumab) have not been effective or are not tolerated. This medicine has not been studied in children under six years of age.

How is this treatment given?

Abatacept is only given under the supervision of specialists.

It is usually given as a drip into a vein (intravenous infusion) over a 30 minute period. This is repeated two and four weeks after the first infusion and then at further intervals of four weeks.

For adults aged over 18 years, abatacept can also be given as an injection under the skin once a week. If appropriate, your doctor may be able to teach you or your carer to administer these injections yourself. In this case you will need to carefully follow the instructions given by your doctor, as well as those printed in the information leaflet supplied with the injections.

If no improvements in symptoms have been seen after six months of using this medicine it may be necessary to stop the treatment.

Warning!

This medicine can compromise the body's ability to fight infections. Cases of other serious infections, including tuberculosis (TB), have been seen in people treated with this medicine. You should be tested for TB and viral hepatitis before treatment is started. Tell your doctor immediately if you experience weight loss, fever or persistent coughing during treatment, as these can be symptoms of TB.

It is important to try and avoid exposure to infections while you are having treatment with this medicine. Let your doctor know as soon as possible if you get any symptoms of any infection, so that it can be treated without delay. If you develop a serious infection, treatment with this medicine should be stopped until the infection is controlled.

Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment with this medicine and for at least 14 weeks after their last dose of this medicine. Seek further medical advice from your doctor.

This medicine contains maltose, which is a type of sugar that can give a falsely high blood glucose reading with certain types of blood glucose monitors. Your doctor or pharmacist will be able to check this for you.

Use with caution in

Elderly people.

Carriers of hepatitis B.

People with dormant (currently inactive) tuberculosis infection.

People with a history of recurrent infections.

People who are, or who have recently been, receiving treatment that suppresses the activity of the immune system, eg long-term oral corticosteroids, chemotherapy, radiotherapy, medicines to prevent transplant rejection.

Multiple sclerosis.

People with a history of or current cancer.

Orencia infusion contains sodium, which should be taken into consideration for people on a controlled-sodium diet. Orencia subcutaneous injection is sodium-free.

Not to be used in

Active tuberculosis.

Severe and uncontrolled infections.

Infection of the blood or body tissues with pus-forming or other pathogenic organisms (sepsis).

Infections due to lowered resistance of the body (opportunistic infections).

Breastfeeding.

Orencia subcutaneous injection is not recommended for children and adolescents under 18 years of age.

Orencia infusion is not recommended for children under six years of age.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine for use during pregnancy has not been established. The manufacturer states that it should not be used during pregnancy unless considered essential by your doctor.

Women who could get pregnant should use an effective method of contraception to prevent pregnancy during treatment, and for at least 14 weeks after their last dose of this medicine.

It is not known if this medicine passes into breast milk. Women should not breastfeed during treatment with this medicine, or for at least 14 weeks after their last dose.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

Upper respiratory tract infections, such as infections of the nose and throat.

Common (affect between 1 in 10 and 1 in 100 people)

Lower respiratory tract infections, for example chest infections such as bronchitis or pneumonia.

Urinary tract infections.

Cold sores.

Conjunctivitis.

Decrease in the number of white blood cells in the blood (leucopenia).

Headache.

Dizziness.

Pins and needles sensations (paraesthesia).

Increase in blood pressure.

Flushing.

Cough.

Disturbances of the gut such as diarrhoea, indigestion, nausea, vomiting or abdominal pain.

Mouth ulcers.

Skin reactions, such as itching, rash or dermatitis.

Increased hair loss (alopecia).

Feeling weak or tired.

Injection site reactions.

Alteration in results of liver function tests.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

Infections of the skin, nails, kidneys, blood or teeth.

Decrease in the number of platelets in the blood (thrombocytopenia).

Increased tendency to bruise.

Depression, anxiety.

Migraine.

Faster or slower than normal heart rate.

Palpitations.

Decrease in blood pressure.

Wheezing or shortness of breath.

Sensation of spinning (vertigo).

Inflammation of the stomach (gastritis).

Weight gain.

Flu-like symptoms.

Heavy menstrual periods or stopping of periods.

Dry skin or eyes.

Joint pain (arthralgia).

Nettle-type rash.

Psoriasis.

Basal cell carcinoma.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

Gut infections.

Throat tightness.

Lymphoma.

Lung cancer.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to make sure that the combination is safe.

Abatacept is not recommended for use with the following medicines, as the combination may increase the risk of serious infections, without an increase in effectiveness against arthritis:

adalimumab

anakinra

certolizumab

etanercept

golimumab

infliximab

rituximab.

There may be an increased risk of infections if this medicine is used to treat people who are or who have recently been receiving treatment that suppresses the activity of the immune system, eg long-term oral corticosteroids, chemotherapy, radiotherapy or medicines to prevent transplant rejection.

This medicine suppresses part of the immune system. This means that vaccines may potentially be less effective if given during treatment, and live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, oral polio, oral typhoid and yellow fever. It is recommended that live vaccines are not given to people being treated with this medicine or within three months of stopping this medicine. Children having this treatment should be brought up to date with the current childhood immunisation schedule before treatment is started.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain abatacept as the active ingredient.